The FDA approved a new pain medication designed to reduce the risks of addiction and overdose linked to opioids like Vicodin and OxyContin on Thursday. The drug, called Journavx, was developed by Vertex Pharmaceuticals and targets short-term pain following surgery or injury.
A New Approach to Pain Relief
Journavx offers a fresh alternative to opioids and over-the-counter pain relievers like ibuprofen and acetaminophen. This is the first new treatment for pain in over 20 years. However, its effectiveness is limited, and the lengthy development process shows how difficult it is to find new solutions for pain management.
Study Results: Modest Relief
In studies with over 870 patients who underwent foot or abdominal surgeries, Journavx worked better than a placebo. However, it did not provide more relief than the commonly used opioid-acetaminophen combination pill. Michael Schuh, a pharmacist at Mayo Clinic, commented, “It’s not a slam dunk on effectiveness. But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot of promise.”
High Cost of the New Drug
Journavx will cost $15.50 per pill. This price is much higher than opioids, which can cost $1 or less when sold as generics. Vertex started developing the drug in the early 2000s, when opioid overdoses were rising due to the over-prescription of painkillers for common conditions. While opioid prescriptions have decreased, illicit fentanyl has become the main cause of the current opioid crisis.
How Journavx Works
Unlike opioids, which bind to brain receptors to block pain, Journavx blocks proteins that send pain signals to the brain. Dr. David Altshuler from Vertex explained, “In trying to develop medicines that don’t have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain.”
Side Effects and Safety Profile
Common side effects include nausea, constipation, itching, rash, and headaches. However, Dr. Charles Argoff, who consulted for Vertex, emphasized that Journavx carries no risk of addiction and has fewer dangerous side effects compared to opioids.
Research Origins and Future Plans
Vertex’s focus on pain-signaling proteins came from research into a rare genetic condition that causes people to feel no pain. Vertex’s drug pipeline, which includes treatments for chronic pain, has attracted significant interest due to its potential. However, the company faced a setback in December when a study of chronic nerve pain didn’t show better results than a placebo.
Despite the disappointing results, Vertex is pressing forward with a new late-stage trial of Journavx. The company hopes a different trial design could improve outcomes and lead to approval for chronic pain treatment.